Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
Recalling firm
American Pharmaceutical Ingredients LLC
NDC code
58597-8634-2
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0483-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.